Using Heart Rate Variability Biofeedback to Improve Attention and Memory in PTSD+ Combat Veterans (HRVB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by William Jennings Bryan Dorn VA Medical Center
Sponsor:
Collaborator:
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
J.P. Ginsberg, Ph.D., William Jennings Bryan Dorn VA Medical Center
ClinicalTrials.gov Identifier:
NCT00625105
First received: February 19, 2008
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

This study will test the effectiveness of Heart Rate Variability (HRV) Biofeedback as a therapeutic tool in the reduction of everyday memory problems routinely experienced by combat veterans with Posttraumatic Stress Disorder (PTSD). The study is innovative in three ways: (1) through its investigation of the clinical use of a novel PTSD treatment technology, (2) by focusing on the understudied aspect of the daily functioning of PTSD veterans, and, (3) by investigating a heretofore untested application of biofeedback for PTSD induced deficits in attention (ATTN) and immediate memory (IM). Though HRV Biofeedback has proven successful for several applications in the general population, the idea that deficits in ATTN/IM in combat veterans with PTSD can be remedied by normalization of HRV has not yet been tested empirically. HRV is functionally incorporated into attentional processes, essentially operating as an index of autonomic flexibility and the ability to self-regulate in response to stimulation from the environment. Low HRV occurs in patients with PTSD, General Anxiety Disorder, and Coronary Artery Disease, and is correlated with negative affect and hostility. HRV Biofeedback training has been shown to be effective in increasing HRV in these groups of patients, as well as improving psychological well-being and physiological function in patients with Depression, Fibromyalgia, and Cardiovascular Disease. Therefore, the interrelationship between HRV and ATTN/IM problems in PTSD+ Combat veterans warrants further investigation. If HRV Biofeedback significantly improves ATTN/IM in these subjects, then it can be offered to VA clinicians treating combat PTSD as an effective new treatment tool.


Condition Intervention
PTSD
Behavioral: Biofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Heart Rate Variability Biofeedback to Improve Attention and Memory in PTSD+ Combat Veterans

Resource links provided by NLM:


Further study details as provided by William Jennings Bryan Dorn VA Medical Center:

Primary Outcome Measures:
  • Heart rate variability [ Time Frame: completion ] [ Designated as safety issue: No ]
  • Attention and immediate memory [ Time Frame: completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biofeedback
HRV coherence biofeedback procedure
Behavioral: Biofeedback
Sham Comparator: Sham intervention
Passive monitor viewing
Behavioral: Biofeedback

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • OIF/OEF veterans with PTSD

Exclusion Criteria:

  • Neurologic disorder
  • Active substance abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625105

Contacts
Contact: J.P. Ginsberg, Ph.D. 803.776.4000 ext 6634 jay.ginsberg@va.gov

Locations
United States, South Carolina
Dorn VA Medical Center Recruiting
Columbia, South Carolina, United States, 29209
Contact: J.P. Ginsberg, Ph.D.    803-776-4000 ext 6634    jay.ginsberg@va.gov   
Sponsors and Collaborators
William Jennings Bryan Dorn VA Medical Center
Congressionally Directed Medical Research Programs
  More Information

No publications provided

Responsible Party: J.P. Ginsberg, Ph.D., Principal Investigator, William Jennings Bryan Dorn VA Medical Center
ClinicalTrials.gov Identifier: NCT00625105     History of Changes
Other Study ID Numbers: JPG001
Study First Received: February 19, 2008
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 16, 2014